SOP: IRB Meeting Preparation



1. PURPOSE

1. This procedure establishes the process to obtain informed consent from subjects, the legally authorized representatives of adults unable to consent, or the parents or guardians.

2. The process begins when an individual identifies a subject as a potential candidate for a research study.

3. The process ends when a subject or the subject’s legally authorized representative provides legally effective informed consent or declines to do so.

2. REVISIONS FROM PREVIOUS VERSION

1. Clarifications on who can serve as an impartial witness

3. POLICY

1. In this SOP “investigator” means a principal investigator or an individual authorized by the principal investigator to obtain consent for the specific protocol, such as a co-investigator, research assistant, or coordinator.

2. In this SOP “subject/representative” means:

1. The subject when the subject is an adult capable of providing consent.

2. Legally authorized representative when the subject is an adult unable to give consent.

3. One or both biologic or adoptive parents when the subject is a child or in the absence of a parent a person other than a parent authorized under applicable law to consent on behalf of the child to general medical care.

3. If the subject is an adult unable to consent:

1. The IRB must have specifically approved the enrollment of adults unable to consent.

2. Permission is obtained from a legally authorized representative.

3. A legally authorized representative must be in the class or persons approved by institutional policy. See SOP “HRP-013: Legally Authorized Representatives, Children, and Guardians.”

4. If the subject is a child:

1. The IRB must have specifically approved the enrollment of children.

2. Permission is obtained from both parents unless one parent is deceased, unknown, incompetent, not reasonably available, or only one parent has legal responsibility for the care and custody of the child, unless the IRB has determined that the permission of one parent is sufficient.

3. In the absence of a parent permission may be obtained from an individual authorized under applicable law to consent on behalf of a child to general medical care.

5. If the subject cannot speak English:

1. The IRB must have approved the enrollment of subjects unable to speak English.

2. If the IRB required translation of the consent document for non-English speaking subjects, the most recent IRB-approved version of the translated consent document must be used.

3. The subject/representative must be given a copy of the consent document written in a language understandable to them. The language of the consent conversation should match the written consent document.

4. Ad hoc translation of the consent document may not be substituted for a written translation, when it is required by the IRB.

5. If the IRB has approved the Short Form Consent process and provided a Short Form Consent for this subject, refer to Materials 6.2.3

6. Conduct all discussions in a private and quiet setting.

7. Any knowledgeable individual may:

1. Review the study with subject/representative to determine preliminary interest.

2. If the subject/representative is interested, notify an investigator.

3. If the subject/representative is not interested, take no further steps regarding recruitment or enrollment.

4. RESPONSIBILITIES

1. The principal investigator is responsible to ensure these procedures are carried out.

5. PROCEDURE

1. If the consent process will be documented in writing with the long form of consent documentation:

1. Obtain the current IRB approved consent form and provide a copy of the consent form to the subject/representative.

1. Verify that you are using the most current IRB-approved version of the study specific consent form.

2. Verify that the IRB-approved consent form is written in a language understandable to the subject/representative.

3. Whenever possible provide the consent form to the subject/representative in advance of the consent discussion.

2. If the subject/representative cannot read or write (regardless of language – i.e. due to visual impairment or illiteracy) obtain an impartial witness (see Reference 7.4 for definition) to be present during the entire consent discussion to attest that the information in the consent form and any other information provided was accurately explained to, and apparently understood by, the subject/representative, and that consent was freely given. The impartial witness may be a family member or friend. If a family member or friend of the potential subject is not available, the impartial witness may be a staff member who is not on the study team. The impartial witness may not be a person involved in the design, conduct, or reporting of the research study.

3. If the subject/representative cannot speak English, and you have an IRB approved translated consent document in the necessary language, obtain the services of a translator fluent in both English and the language understood by the subject/representative.

4. Read (or have a translator read) the consent document (or translated consent document) along with the subject/representative and explain the details in such a way that the subject/representative understands what it would be like to take part in the research study.

2. If the consent process will be documented in writing with the short form of consent documentation:

1. Obtain the current IRB approved short consent form and summary (same as the IRB approved English consent form used for long form of consent documentation) and provide copies to the subject/representative.

1. Verify that you are using the most current IRB-approved version of the short consent form and summary (long form consent).

2. Verify that the written short consent form is in language understandable to the subject/representative.

3. Whenever possible provide the short consent form and summary to the subject/representative in advance of the consent discussion.

2. Follow hospital policy and procedure on Limited English Proficiency (GPP-305):

3. Obtain the services of an authorized medical interpreter (under Hospital Policy GPP-305) fluent in both English and the language understood by the subject/representative. The interpreter may NOT be a member of the research team, family member or friend of the subject/representative.

4. Obtain the services of an impartial witness to be present during the entire consent discussion to attest that the information in the short consent form, summary, and any other information provided was accurately explained to, and apparently understood by, the subject/representative, and that consent was freely given. The impartial witness may be a family member or friend. If a family member of friend of the potential subject is not available, the impartial witness may be a staff member who is not on the study team. The impartial witness may not be a person involved in the design, conduct, or reporting of the research study. The impartial witness and the interpreter may be the same person if the interpreter is present in the room, unless the interpreter is authorized to obtained consent.

5. Have the interpreter translate the summary (the English long consent document - not the short consent form) to the subject/representative.

6. Through the interpreter, explain the details in such a way that the subject/representative understand what it would be like to take part in the research study. When necessary provide a different or simpler explanation to make the information understandable.

7. Have the subject/representative read the short consent form or have the interpreter read the short consent form to the subject/representative.

3. If the requirement for written documentation of the consent process has been waived by the IRB:

1. Obtain the current IRB approved consent script and provide a copy to the subject/representative. If HIPAA applies, and you are obtaining consent and HIPAA authorization by phone for a minimal risk study, you must also follow Hospital Policy MI-6 2C Phone Consents for Minimal Risk Studies.

1. Verify that you are using the most current IRB-approved version of the study script.

2. Whenever possible provide the script to the subject/representative in advance of the consent discussion.

4. Invite and answer the subject/representative’s questions.

5. Give the subject/representative time to discuss taking part in the research study with family members, friends and other care providers as appropriate.

6. Invite and encourage the subject/representative to take the written information home to consider the information and discuss the decision with family members and others before making a decision.

7. Ask the subject/representative questions to determine whether all of the following are true, and if not, either continue the explanation or determine that the subject/representative is incapable of consent:

1. The subject/representative understands the information provided.

2. The subject/representative does not feel pressured by time or other factors to make a decision.

3. The subject/representative understands that there is a voluntary choice to make.

4. The subject/representative is capable of making and communicating an informed choice.

8. If the subject/representative has questions about treatments or compensation for injury, provide factual information and avoid statements that imply that compensation or treatment is never available.

9. If the study is a clinical trial and the investigator above is not a physician or physician extender, a physician or physician extender must complete the following steps.

1. Invite and answer the subject/representative’s questions.

2. Confirm that the following are true or repeat the above steps:

1. The subject/representative understands the information provided.

2. The subject/representative does not feel pressured by time or other factors to make a decision.

3. The subject/representative understands that there is a voluntary choice to make.

4. The subject/representative is capable of making and communicating an informed choice.

10. Once a subject/representative indicates that he or she does not want to take part in the research study, this process stops.

11. If the subject/representative agrees to take part in the research study:

1. If the subject is a child:

1. Whenever possible explain the research to the extent compatible with the child’s understanding.

2. Request the assent (affirmative agreement) of the child unless:

1. The capability of the child is so limited that the child cannot reasonably be consulted.

2. The IRB determined that assent was not a requirement.

3. Once a child indicates that he or she does not want to take part in the research study, this process stops.

2. If the subject is an adult unable to consent:

1. Whenever possible explain the research to the extent compatible with the adult’s understanding.

2. Request the assent (affirmative agreement) of the adult unless:

1. The capability of the adult is so limited that the adult cannot reasonably be consulted.

2. The IRB determined that assent was not a requirement.

3. Once an adult unable to consent indicates that he or she does not want to take part in the research study, this process stops.

3. Obtain written documentation of the consent process according to SOP HRP-091: Written Documentation of Consent.

6. MATERIALS

1. Long form of consent documentation:

1. Consent form

2. Short form of consent documentation:

1. Short consent form

2. Summary (same as the English consent form used for long form of consent documentation)

3. Policy: Enrollment of Non-English Speaking Subjects in Research

3. Requirement for written documentation of the consent process has been waived by the IRB:

1. Consent script (same content as consent form used for long form of consent documentation except that signature block is optional)

4. SOP “HRP-013: Legally Authorized Representatives, Children, and Guardians.”

5. SOP “HRP-091: Written Documentation of Consent.”

7. REFERENCES

1. Hospital Policy on Informed Consent

2. Institutional Policy: Services for Limited English Proficiency Patients

3. 21 CFR 50.20, 50.25

4. 45 CFR 46.116

5. ICH GCP E6. Definition of Impartial Witness: A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process, and who reads the informed consent form and any other written information supplied to the subject.

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